Manager Clinical Quality Assurance

Manager Clinical Quality Assurance

Octapharma

Vienna, Austria

Your new challenges which will inspire you:

  • Provide active support in the continuous improvement at of the Clinical R&D Quality Management System, identify compliance weaknesses, work with staff to identify possible root cause and develop effective corrective and preventive actions;
  • Act as QA representative for operational teams and support functions: Actively contribute to problem solving, give support to operational teams and support functions as regard to quality related issues;
  • Review and give guidance to the development of clinical SOPs owned by CR&D and Global Medical Affairs and ensure that processes described in SOPs are in compliance with applicable regulations;
  • Manage the CR&D training program (maintenance of training records, planning and performance of staff training, organize training sessions);
  • Evaluate vendor qualification (from QA point of view) to support overall vendor qualification;
  • Perform audits at clinical study sites and vendors supporting clinical studies to evaluate compliance with GCP and with the regulations;
  • Accompany and support regulatory inspections.

Your profile that will convince us:

  • University degree (preferably medical or biosciences);
  • At least 3 years’ experience in the Pharmaceutical or CRO Industry, preferably in Clinical QA or Clinical Operations;
  • Strong analytical, problem-solving skills with excellent written and verbal communication skills;
  • Strong organizational, presentation, documentation and interpersonal skills;
  • Excellent English;
  • Team oriented & willingness to travel (travel time up to 50%).

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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